Table I.
Multivariate outcomes of cirAE incidence and severity by LDH category
| Outcome* | OR‡ (95% CI) | P value¶ |
|---|---|---|
| Development of cirAE (any type) | ||
| High LDH† at pre-ICI baseline | 0.37 (0.14–0.92) | .033 |
| High LDH at >3 months post-ICI | 0.30 (0.12–0.77) | .013 |
| Development of cirAE (subtypes) | ||
| Macular and papular rash | ||
| High LDH at pre-ICI baseline | 0.19 (0.02–1.93) | NS |
| High LDH at >3 months post-ICI | 1.15 (0.24–5.59) | NS |
| Pruritus | ||
| High LDH at pre-ICI baseline | 1.43 (0.35–5.84) | NS |
| High LDH at >3 months post-ICI | 0.51 (0.09–2.85) | NS |
| Rash NOS | ||
| High LDH at pre-ICI baseline | 1.83 (0.52–6.48) | NS |
| High LDH at >3 months post-ICI | 0.97 (0.25–3.77) | NS |
| Other | ||
| High LDH at pre-ICI baseline | 0.82 (0.18–3.78) | NS |
| High LDH at >3 months post-ICI | 1.63 (0.38–7.03) | NS |
| Low cirAE severity among all patients§ | ||
| High LDH at pre-ICI baseline | 1.43 (0.47–4.29) | NS |
| High LDH at >3 months post-ICI | 3.80 (0.78–10.03) | NS |
| High cirAE severity among all patients§ | ||
| High LDH at pre-ICI baseline | 0.70 (0.23–2.11) | NS |
| High LDH at >3 months post-ICI | 0.36 (0.10–1.28) | NS |
| Low cirAE severity among cirAE patientsǁ | ||
| High LDH at pre-ICI baseline | 0.70 (0.20–2.51) | NS |
| High LDH at >3 months post-ICI | 1.80 (0.45–7.18) | NS |
| High cirAE severity among cirAE patientsǁ | ||
| High LDH at pre-ICI baseline | 1.42 (0.40–5.05) | NS |
| High LDH at >3 months post-ICI | 0.56 (0.14–2.23) | NS |
CI, Confidence interval; cirAE, cutaneous immune-related adverse event; ICI, immune checkpoint inhibitor; LDH, lactate dehydrogenase; NOS, not otherwise specified; NS, not significant; OR, odds ratio.
Binomial logistic regression was used for all models. All models included age at the start of ICI regimen, sex, and additional clinical features significant to P<.10 as covariates, with details as follows for each model:Development of cirAE (any type): age, sex, Eastern Cooperative Oncology Group (ECOG) status, history of kidney disease, any irAE.Development of cirAE (subtypes): age, sex, ECOG status, history of kidney disease, any irAE.Low or high cirAE severity among all patients: age, sex, ECOG status, history of kidney disease, any irAE.Low or high cirAE severity among cirAE patients: age, sex, ECOG status, history of kidney disease, any irAE.
LDH values were categorized into “high” (>210 U/L) and “low” (≤210 U/L) based on our institution’s laboratory reference range, with 210 U/L being the upper limit of normal.
Reference LDH category for all models is LDH value of “low” (≤210 U/L).
cirAE severity was categorized based on peak CTCAE v5.0 grade as determined by any evaluating physician. Category of “high” includes grades 2, 3, or 4 and “low” includes grade 1. Reference cirAE category for models is having no history of cirAE.
cirAE severity was categorized based on peak CTCAE v5.0 grade as determined by any evaluating physician. Category of “high” includes grades 2, 3, or 4 and “low” includes grade 1. Reference cirAE category for low cirAE severity models is having no history of grade 1 cirAE. Reference cirAE category for high cirAE severity models is having no history of grades 2–4 cirAE.
Bolded P values represent statistical significance to P<.05.